Pharmaceutical Product Quality Review, Drug Stability and Regulations Consultant

Expertise

• Manage pharmaceutical commercial internal-external stability programs providing, guidance for laboratory investigations, input for laboratory information management systems, support sample management programs, and support data review. Provide support to Operational Excellence Projects.
• Ensuring stability studies are conducted to support regulatory commitments.
• Communicating trending stability data from the QC laboratory and contract laboratories.
• Drug stability program management for development and commercial products.
• Statistical analysis of analytical data.(Slim Stat).
• Consulting support for stability sections of regulatory submissions, sNDAs and annual reports (APQR)-Annual Product Quality Review.
• Quality representative to project teams. Overseeing contract laboratories that conduct stability studies.
• Drafting and revising protocols and working instructions for the stability program.
• Internal and external audit.
• Reviewing, approving and closing stability protocols in laboratory information management system.
• Writing stability sections of IND's, CTD and annual reports.
• Lab investigation management.
• Oversee sample management personnel in setting up stability studies and pulling stability samples.
• Annual product quality report review for commercial products.
• Assessing temperature excursions for drug product and drug substances.
• Method and knowledge transfer to Europe.

Experience

Independent Contractor, Present

• Providing clients with overall pharmaceutical activity support: Regulatory, stability protocols, quality control, laboratory investigations and written assessments.

Astra Zeneca,(Amylin Pharmaceuticals), San Diego, CA, 2013 - 2015

Associate Director - Quality Assurance and Regulatory Support

• Ensuring stability studies are conducted to support regulatory commitments.
• Responsible for trending stability data from the QC laboratory and contract laboratories.
• Provide statistical analysis of analytical data.(Slim Stat)
• Responsible for providing support for stability sections of regulatory submissions, sNDAs and annual reports (APQR).
• Serve as the Quality Representative to project teams.
• Overseeing contract laboratories that conduct stability studies.
• Writing and revising stability protocols.
• Reviewing, approving and closing stability protocols in laboratory information manageme system.
• Coordinating initiation of stability studies with Supply Operations and the QC laboratory.
• Oversee sample management personnel in setting up stability studies and pulling stability samples.
• Provide guidance for laboratory investigations.
• Drafting and revising standard operating procedures for the stability program as needed.
• Provide input and guidance for the laboratory information management system program.
• Provide input and guidance for the sample management program.
• Assessing temperature excursions for drug product and drug substances.
• Support internal and external audits when needed.
• Support Operational Excellence projects.

Manager, 2008 - 2013

• Responsible for providing results and writing stability sections of regulatory submissions, sNDAs and annual reports APQR).
• Serve as the QA representative to project teams.
• Overseeing contract laboratories that conduct stability studies.
• Identifying drug substance and drug product lots for use in stability studies.
• Writing and revising stability protocols.
• Reviewing, approving and closing stability protocols in laboratory information management system.
• Coordinating initiation of stability studies with Supply Operations and the QC laboratory.
• Support sample management personnel in setting up stability studies and pulling stability samples.
• Responsible for Quality review of data generated by QC analysts and contract laboratories.
• Responsible for trending stability data from the QC laboratory and contract laboratories.
• Provide statistical analysis of analytical data.
• Provide guidance for laboratory investigations.
• Drafting and revising standard operating procedures for the stability program as needed.
• Assessing temperature excursions for drug product and drug substances.

Senior Quality Analyst

• Accurate, thorough and timely review and/or approval of analytical documentation.
• Data entry of analytical results and/or review and approval in LIMS.
• Identify/review and follow up on analytical related deviations, observations, findings, and corrective actions.
• Trend release and stability data using validated statistical packages.
• Conduct and follow up on investigations for out-of-trend or out-of-specification data.
• Help resolve potential or existing quality issues that may jeopardize regulatory compliance.
• Maintain open, effective communication with other Amylin departments and analytical contract service providers for analytical review activities and issues.

Ligand Pharmaceuticals, San Diego, CA, AD Scientist, 2005 - 2006

• QC and stability data management of commercial and development products, raw materials, synthetic intermediates and drug substances. Generation of stability data reports and protocols.
• Review of stability study protocols, data and reports in accordance with current regulatory guidelines.
• Developing appropriate systems and procedures with regards to the performance and monitoring of drug substance and drug product stability.
• Coordinating the activities of contract laboratories as they pertain to either drug substance or drug product stability.
• Writing appropriate analytical stability reports required for the CMC section of IND's, NDA's and other regulatory filings. Tracking expenses and budgeting for contracted stability studies.

La Jolla Pharmaceuticals, San Diego, CA, Analytical Development Chemist, 2002 - 2005

• Developed and validated HPLC methods in support of NDA submission and formulations research.
• Developed HPLC purity and assay methods for Riquent™, formerly known as LJP 394, for the treatment of patients with lupus kidney disease, a leading cause of sickness and death in these patients.
• Worked on development and assessment of new formulation for LJP 1082.
• Writing SOPs, calibration procedures, and technical reports.
• Worked under tight stability deadlines with many projects coordinated simultaneously, within FDA Guidelines.

Magellan Laboratories, San Diego, CA, Chemist III, 2000 - 2002

• Developed test methods and supported method development.
• Worked with Biopharmaceutical Chemistry Group as Chemist III.
• Developed methods independently and also as a group.
• Trained new employees on complicated methods and equipment.

Honors & Publications

Credentials

• Part of the team of recently approved Type 2 diabetes drug.
• Successfully transferred commercial stability program for approved drugs to new site of the company.
• Improving Your Project Management Skills-American Management Association
• Drug Product Stability and Shelf life- The Center of Professional Advancement
• Lab Week-Instutute of Validation Technology
• IVT's 3rd Annual Forum - Stability Programs
• Quality Systems for Medical Devices: FDA's QSR and ISO 13485

Languages

• Turkish

Education

• M.S. Analytical Chemistry, San Diego State University, San Diego, CA